AB0889 FILGOTINIB FOR THE TREATMENT OF SYSTEMIC SCLEROSIS OVERLAP RHEUMATOID ARTHRITIS: DATA FROM OUR PRELIMINARY EXPERIENCE
Authors: M. De Pinto, A. Spinella, L. Gavioli, G. Amati, A. Rai, F. Goatelli, P. Macripo’, F. Lumetti, O. Secchi, G. Sandri, C. Salvarani, D. Giuggioli
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Systemic sclerosis is a connective tissue disease characterized by endothelial disfunction and fibrosis of the skin and internal organs. JAK inhibitors has shown efficacy in reducing cutaneous and pulmonary fibrosis in mice models of SSc, but only few case reports and no RCTs are reported in literature. SSc is frequently associated with other autoimmune diseases and SSc- Rheumatoid arthritis (RA) is one of the most common SSc-Overlap Syndrome. Filgotinib is an oral selective JAK1 inhibitor, recently approved for the treatment of RA. <h3>Objectives</h3> The aim of our work was to assess efficacy and safety of Filgotinib for the treatment of cutaneous, visceral and articular involvement in patients affected by SSc overlap RA. <h3>Methods</h3> Prospective, open-label, monocentric study in which 5 patients affected by SSc overlap RA (M/F 0/5, age 57,80±16,62DS years, disease duration 11,6±7,89 DS years, limited/diffuse subset 3/2) referring to the Scleroderma Units of Modena and Reggio Emilia between October 2021 and July 2022, were enrolled. All patients satisfied both ACR/EULAR criteria for SSc and RA and were already in treatment with standard therapy (prostanoids, calcium-channel blockers a/o endothelin-receptors inhibitors a/o phosphodiesterase type 5 inhibitors) and had an inadequate response or were intolerant or had contraindication to one or more DMARDs or bDMARDs. Patients received Filgotinib 200 mg once daily for a period of 24 weeks. Articular, cutaneous and visceral involvement were assessed according to clinical practice at the baseline and at 12th and 24th week after the start of the treatment. <h3>Results</h3> All patients showed a significant improvement in articular involvement at 24<sup>th</sup> week, in particular a significant reduction in tender joint count (TJ, p=0,003), SDAI/CDAI (p=0,012/0,008) and pain numerical rating scale (NRS, p=0,035) was reported. A trend of improvement of DAS28 (p=0,055) was also observed. Notably a significant reduction in TJ (p=0,023) and a trend of improvement of SDAI/CDAI (p=0,059/0,051) was already seen at 12<sup>th</sup> week. The extent and severity of skin involvement assessed through modified Rodnan Skin Score (mRSS) remained stable during follow-up (p=0,918). No improvement or worsening of exertional dyspnea measured by means of Borg scale was reported. No drug-related side effects were recorded during follow-up and none of the patients discontinued the treatment. No deaths were reported. <h3>Conclusion</h3> According to our preliminary data, Filgotinib was effective, safe and well tolerated in the treatment of articular involvement in patients affected by SSc overlap RA. Further analysis on a larger number of patients and control group are needed to confirm our data. Patients' enrollment with assessment of efficacy on skin and lung involvement is currently ongoing. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.